Disc Medicine posts corporate deck highlighting bitopertin in EPP pipeline progress
Disc Medicine, Inc.
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- Disc Medicine outlined plans to file a complete response to the FDA by end-2026 for bitopertin in EPP.
- FDA Type A meeting alignment that the Phase 3 APOLLO trial could support the CRL response and a traditional approval if positive.
- APOLLO enrollment completed in March 2026 with 183 patients; topline data expected in Q4 2026.
- HELIOS open-label extension showed sustained PPIX reductions beyond 1 year; median exposure 25.3 months with 5% Grade 3 TEAEs.
- RALLY-MF Phase 2 update for selcodebart showed 72% overall response and 56% major response; positioned for about 22,000 anemic MF patients.
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